Apomigra

Leaflet attached to the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

ApoMigra (Sumatriptan Aurobindo), 50 mg, tablets

Sumatriptanum
ApoMigra and Sumatriptan Aurobindo are different trade names for the same medicine.

The contents of the leaflet must be carefully read before taking the medicine, as it contains important information for the patient.

• The leaflet should be kept so that it can be re-read if necessary.
• In case of any further doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed specifically for one person. It should not be given to others.
• The medicine may harm another person, even if the symptoms of their illness are the same.
• If any of the side effects worsen or any side effects not mentioned in the leaflet occur, the doctor, pharmacist, or nurse should be informed.

Table of contents of the leaflet:

1
What ApoMigra is and what it is used for

• 2. Important information before taking ApoMigra
• 3. How to take ApoMigra
• 4. Possible side effects
• 5. How to store ApoMigra
• 6. Contents of the pack and other information

1. What ApoMigra is and what it is used for

ApoMigra belongs to a group of medicines called triptans (also known as 5HT receptor agonists).
ApoMigra is used to treat migraine attacks.
Migraine symptoms may be caused by temporary blood vessel dilation in the head. It is thought that ApoMigra causes the dilation of blood vessels to decrease. This, in turn, helps to eliminate headache and alleviate other symptoms of a migraine attack, such as nausea or vomiting and sensitivity to light and sound.

2. Important information before taking ApoMigra

When not to take ApoMigra

• monoamine oxidase inhibitors (MAOIs) or have taken an MAOI in the last 2 weeks,
• selective serotonin reuptake inhibitors (SSRIs) including citalopram, fluoxetine, fluvoxamine, paroxetine, or sertraline,
• serotonin and noradrenaline reuptake inhibitors (SNRIs) including venlafaxine and duloxetine,
• in children under 18 years of age.

If any of the above situations apply to the patient:

Contact a doctor and do not take ApoMigra.

Warnings and precautions

Talk to a doctor or pharmacist before taking ApoMigra.
Additional risk factors apply to the patient:

In very rare cases, some patients have developed severe heart disorders after taking sumatriptan, even if they had no previous symptoms of heart disease. If any of the above points apply to the patient, it may mean that the patient is at increased risk of heart disease, so the doctor should be informed, who should check the heart function before prescribing sumatriptan.
If the patient has a history of seizure disorders
Or if the patient has other conditions that may increase the likelihood of having a seizure – such as head injury or alcoholism. The doctor should be informed so that they can closely monitor the patient.
If the patient has high blood pressure, ApoMigra may not be suitable for them.
Before starting to take ApoMigra, the doctor or pharmacist should be told.
If the patient has liver or kidney disease
If this applies to the patient, before starting to take ApoMigra, the doctor or pharmacist should be told.
If the patient has an intolerance to some sugars
The doctor should be informed so that they can closely monitor the patient.
If the patient is allergic to sulfonamide medicines
In such a case, the patient may also be allergic to ApoMigra. If the patient is allergic to an antibiotic but does not know if it belongs to the sulfonamide group, they should tell the doctor or pharmacist before taking this medicine. Before starting to take ApoMigra, the doctor or pharmacist should be told.
If the patient is taking SSRI (selective serotonin reuptake inhibitor) or SNRI (serotonin and noradrenaline reuptake inhibitor) antidepressant medicines.
Before starting to take ApoMigra, the doctor or pharmacist should be told.
See also the section below “ApoMigra and other medicines”.
If the patient frequently uses ApoMigra
Taking sumatriptan too often may cause the headache to worsen. If this applies to the patient, the doctor should be told. The doctor may advise stopping the use of sumatriptan.
If the patient feels pain or pressure in the chest after taking ApoMigra.
Such symptoms may be intense but usually pass quickly. However, if the symptoms do not pass quickly or become severe, medical help should be sought immediately. More information on possible side effects can be found in section 4 of the leaflet.

ApoMigra and other medicines

Tell the doctor about all medicinescurrently being taken or recently taken, as well as any medicines that the patient plans to take. This includes all herbal preparations and medicines that have been purchased without a prescription.
Certain medicines must not be taken with ApoMigra, and others may cause side effects if taken at the same time as this medicine. The doctor should be informed if the patient is taking:

• Ergotamineused to treat migraineor medicines that work in a similar way, such as methysergide (see section 2). ApoMigra must not be taken at the same time as these medicines. The patient should stop taking these medicines at least 24 hours before starting to take ApoMigra. The patient should not take them again for at least 6 hours after finishing the treatment with ApoMigra.
• Other triptans or 5HT receptor agonists(such as naratriptan, rizatriptan, zolmitriptan), as well as other medicines used to treat migraine (see section 2). ApoMigra must not be taken at the same time as these medicines. The patient should stop taking these medicines at least 24 hours before starting to take ApoMigra. The patient should not take them again for at least 24 hours after finishing the treatment with ApoMigra.
• Monoamine oxidase inhibitors (MAOIs), used to treat depression. ApoMigra must not be taken if the patient has taken such medicines in the last 2 weeks.
• Selective serotonin reuptake inhibitors (SSRIs)and serotonin and noradrenaline reuptake inhibitors (SNRIs), used to treat depression. Taking ApoMigra with these medicines may cause serotonin syndrome (a condition that can include restlessness, confusion, sweating, hallucinations, increased reflexes, muscle stiffness, shivering, fast heart rate, and trembling). The doctor should be told immediately if such symptoms occur.
• St. John's Wort (Hypericum perforatum). When taking ApoMigra and herbal medicines containing St. John's Wort, side effects may occur more often.

Pregnancy, breastfeeding, and fertility

• If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should tell their doctor before taking this medicine. Experience with the safety of sumatriptan during pregnancy is limited. So far, available data do not indicate an increased risk of congenital anomalies. The patient should discuss with their doctor whether they can take ApoMigra during pregnancy.
• The patient should not breastfeed their baby for 12 hours after taking ApoMigra. Milk expressed during this time should be discarded and not given to the baby.

Driving and using machines

Migraine symptoms or the medicine may cause drowsiness. If this symptom occurs, the patient should not drive or operate machinery.

ApoMigra contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially “sodium-free”.

3. How to take ApoMigra

ApoMigra should always be taken according to the doctor's or pharmacist's advice. In case of doubts, the doctor or pharmacist should be consulted.
ApoMigra is available in the following strengths: 50 mg and 100 mg.
When to take ApoMigra

• It is best to take ApoMigra as soon as the patient feels a migraine coming on, although it can be taken at any time during an attack.
• ApoMigra should not be taken to prevent an attack - it should only be taken after migraine symptoms have started.

Dosage:
Adults aged 18 to 65 years

• The usual dose for adults aged 18 to 65 years is one ApoMigra 50 mg tablet, swallowed whole and taken with water. Some patients may need a 100 mg dose - the doctor's advice should be followed.

Children and adolescents under 18 years of age
ApoMigra is not recommended for children and adolescents under 18 years of age.
Elderly patients (over 65 years)
ApoMigra is not recommended for patients over 65 years of age.
If symptoms start to return:

• The patient may take a second ApoMigra tablet if at least 2 hours have passed since the previous tablet was taken. No more than 300 mg should be taken in 24 hours.

If the first tablet does not provide relief

• The patient should not take a second tablet or any other sumatriptan-containing medicine for the same attack. ApoMigra may be used again for a subsequent attack.

If ApoMigra does not provide any relief:

• The patient should ask their doctor or pharmacist for advice.

Taking more than the recommended dose of ApoMigra

• No more than six 50 mg tablets or three 100 mg tablets (a total of 300 mg) should be taken in 24 hours.

Taking too much ApoMigra may cause illness. If the patient has taken more than 300 mg in 24 hours:
The doctor should be contacted for advice.
In case of any further doubts about taking this medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, ApoMigra can cause side effects, although not everybody gets them.
Some symptoms may be caused by the migraine itself.
Allergic reactions: medical help should be sought immediately.
The following side effects have occurred with unknown frequency(frequency cannot be estimated from the available data):

• Allergic symptoms including skin rash, hives (itchy rash); wheezing; swollen eyelids, face, or lips; collapse. If any allergic reactions occur soon after taking ApoMigra, the patient should stop taking the medicine and seek medical advice immediately.

Common (may affect up to 1 in 10 people):

• Pain, heaviness, pressure, or tightness in the chest, throat, or other parts of the body or unusual sensations, including numbness, tingling, and warmth or cold. These sensations may be intense but usually pass quickly. If these symptoms persist or become severe (especially chest pain), medical help should be sought immediately. In a small number of people, these symptoms may be caused by a heart attack.

Other side effects include:

• Nausea (feeling sick) or vomiting, although this may be caused by the migraine itself.
• Fatigue or drowsiness.
• Dizziness, feeling weak, or flushing.
• Temporary increase in blood pressure.
• Shortness of breath.
• Muscle pain.

Very rare (may affect up to 1 in 10,000 people):

• Liver function disorders. If the patient is going to have a blood test to check liver function, they should tell their doctor or nurse that they are taking ApoMigra.

In some patients, the following side effects may occur with an unknown frequency:

• seizures (fits), involuntary movements, neck stiffness;
• vision disturbances such as blurred vision, limited vision, double vision, loss of vision, and in some cases even permanent vision loss (these may also be symptoms of the migraine itself);
• heart disorders, in which the heart may beat faster, slower, or irregularly, chest pain (angina), or heart attack;
• pale, blue-tinged skin and/or pain in the fingers of the hands, toes, ears, nose, or jaw in response to cold or stress (Raynaud's phenomenon);
• feeling faint (low blood pressure);
• diarrhea;
• joint pain;
• feeling restless;
• increased sweating;
• in a patient who has recently had an injury or has an inflammatory condition (such as rheumatism or colitis), pain or worsening of pain at the site of injury or inflammation may occur;
• difficulty swallowing.

Reporting side effects

If any side effects occur, including any not mentioned in the leaflet, the doctor, pharmacist, or nurse should be told. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store ApoMigra

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
No special storage precautions are required.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of medicines that are no longer required. This will help protect the environment.

6. Contents of the pack and other information

What ApoMigra contains

• The active substance of ApoMigra is sumatriptan (Sumatriptanum). Each tablet contains 50 mg of sumatriptan (as sumatriptan succinate).
• The other ingredients are: croscarmellose sodium, polysorbate 80, calcium hydrogen phosphate, microcrystalline cellulose, sodium bicarbonate, magnesium stearate.

What ApoMigra looks like and contents of the pack

White to almost white, oval, biconvex, uncoated tablets with 'C' engraved on one side and '33' on the other side.
ApoMigra is available in blisters containing 6 tablets in a cardboard box.
For more detailed information, the Marketing Authorisation Holder or the Parallel Importer should be contacted.

Marketing Authorisation Holder in the Netherlands, the country of export:

Aurobindo Pharma B.V.
Baarnsche Dijk 1
3741 LN Baarn
Netherlands

Manufacturer:

APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate
Birzebbugia, BBG 3000
Malta

Parallel Importer:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Netherlands Marketing Authorisation number: RVG 34979

Parallel Import Authorisation number: 221/25

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Czech Republic:
Sumatriptan Aurovitas
Italy:
Sumatriptan Aurobindo Italia
Malta:
Sumatriptan Aurobindo 50 mg/100 mg tablets
Poland:
ApoMigra
Portugal:
Sumatriptano Aurovitas

Date of revision of the leaflet: 26.06.2025

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